Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-21 @ 11:13 AM
Study NCT ID:
NCT02913456
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2016-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 629}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences', 'timeFrame': 'Baseline up to 8 years'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Total Number of Treatment Regimens Received by Participants', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Percentage of Participants with HER2 Re-testing of Metastases', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Percentage of Participants with Change in HER2 Status', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH])', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'EuroQol 5-Dimensions Questionnaire (EQ-5D) Score', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Total Healthcare Cost', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Cost of Treating Associated AEs', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Resource Utilization: Percentage of Participants with Hospitalization', 'timeFrame': 'Baseline up to 8 years'}, {'measure': 'Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits', 'timeFrame': 'Baseline up to 8 years'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time\n\nExclusion Criteria:\n\n\\- Not applicable'}, 'identificationModule': {'nctId': 'NCT02913456', 'briefTitle': 'A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'MO39146'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HER2-positive unresectable LA/mBC', 'description': 'Participants with HER2-positive unresectable LA/mBC diagnosed up to 6 months prior to enrollment will be included in the study. Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LA/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '9020', 'city': 'Klagenfurt', 'country': 'Austria', 'facility': 'Klinikum Klagenfurt; Abt. f. Hämatologie u. internistische Onkologie', 'geoPoint': {'lat': 46.62472, 'lon': 14.30528}}, {'zip': '8700', 'city': 'Leoben', 'country': 'Austria', 'facility': 'LKH Hochsteiermark; Abt. für Hämato-Onkologie', 'geoPoint': {'lat': 47.3765, 'lon': 15.09144}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz Elisabethinen ; I. INTERNE ABT.', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '4910', 'city': 'Ried-innkreis', 'country': 'Austria', 'facility': 'A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.'}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universität Wien; Univ.Klinik für Innere Medizin I', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Hanusch-Krankenhaus; Geburtshilfliche und Gynäkologische Abteilung', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '9500', 'city': 'Villach', 'country': 'Austria', 'facility': 'A.Ö. Lhk Villach; Abt. Für Gynäkologie', 'geoPoint': {'lat': 46.61028, 'lon': 13.85583}}, {'zip': '2700', 'city': 'Wiener Neustadt', 'country': 'Austria', 'facility': 'Landesklinikum Wiener Neustadt; Innere Medizin, Hämatologie u. internistische Onkologie', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Treatment Central Onco Hospital OOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4004', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Complex Oncological Center - Plovdiv, EOOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7000', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Mdozs - Russe', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1330', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MHAT Nadezhda', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Tokuda Hospital; Medical Oncology Department', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1784', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'SHATOD - Sofia', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '8018', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Complex Oncology Center-Burgas; Medical Oncology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '8000', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': 'District Oncology Dispensary; Dept of Chimiotherapy', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'District Oncology Dispensary Wit Stationary', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '3000', 'city': 'Vratsa', 'country': 'Bulgaria', 'facility': 'Comprehensive Oncology Center - Vratsa', 'geoPoint': {'lat': 43.21052, 'lon': 23.56312}}, {'zip': '70124', 'city': 'Bari', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '70051', 'city': 'Barletta', 'state': 'Apulia', 'country': 'Italy', 'facility': 'Ospedale Barletta - Mons. Dimiccoli; Dip. Oncologia', 'geoPoint': {'lat': 41.31429, 'lon': 16.28165}}, {'zip': '41124', 'city': 'Modena', 'state': 'Emilia-Romagna', 'country': 'Italy', 'facility': 'A.O. Universitaria Policlinico Di Modena; Oncologia', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '33081', 'city': 'Aviano (PN)', 'state': 'Friuli Venezia Giulia', 'country': 'Italy', 'facility': 'RCCS - Centro di Riferimento; Oncologia Medica B', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '04100', 'city': 'Latina', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ospedale S. Maria Goretti; Divisione Di Oncologia Medica', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '03039', 'city': 'Sora', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ospedale S.S. Trinità Nuovo; Divisione Oncologia', 'geoPoint': {'lat': 41.71829, 'lon': 13.61356}}, {'zip': '01100', 'city': 'Viterbo', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ospedale Belcolle Di Viterbo; Oncologia', 'geoPoint': {'lat': 42.41937, 'lon': 12.1056}}, {'zip': '25123', 'city': 'Brescia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '13875', 'city': 'Ponderano (BI)', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica', 'geoPoint': {'lat': 45.53846, 'lon': 8.05592}}, {'zip': '95126', 'city': 'Catania', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Ospedale Cannizzaro, Oncologia', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '90146', 'city': 'Palermo', 'state': 'Sicily', 'country': 'Italy', 'facility': 'Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '60121', 'city': 'Ancona', 'state': 'The Marches', 'country': 'Italy', 'facility': 'A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '55100', 'city': 'Lucca', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Ospedale San Luca; Oncologia', 'geoPoint': {'lat': 43.84369, 'lon': 10.50447}}, {'zip': '06132', 'city': "Sant'Andrea Delle Fratte (PG)", 'state': 'Umbria', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica'}, {'zip': '35012', 'city': 'Camposampiero', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Ospedale Civile; Oncologia Medica', 'geoPoint': {'lat': 45.56368, 'lon': 11.93534}}, {'zip': '44124', 'city': 'Cona (FE)', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia', 'geoPoint': {'lat': 45.18388, 'lon': 12.01967}}, {'zip': '37045', 'city': 'Legnago (VR)', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Azienda ULSS 21 Ospedale Mater Salutis; Dip. di Oncologia', 'geoPoint': {'lat': 45.19365, 'lon': 11.30227}}, {'zip': '37134', 'city': 'Verona', 'state': 'Veneto', 'country': 'Italy', 'facility': 'A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '2801-951', 'city': 'Almada', 'country': 'Portugal', 'facility': 'Hospital Garcia de Orta; Servico de Oncologia Medica', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'IPO de Coimbra; Servico de Oncologia Medica', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1150-314', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital Santo Antonio dos Capuchos;Servico de Oncologia Medica', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Maria; Servico de Oncologia Medica', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '2674-514', 'city': 'Loures', 'country': 'Portugal', 'facility': 'Hospital Beatriz Angelo; Departamento de Oncologia', 'geoPoint': {'lat': 38.83091, 'lon': -9.16845}}, {'zip': '4200-072', 'city': 'Porto', 'country': 'Portugal', 'facility': 'IPO do Porto; Servico de Oncologia Medica', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '510073', 'city': 'Alba Iulia', 'country': 'Romania', 'facility': 'County Hospital Alba; Oncology', 'geoPoint': {'lat': 46.06667, 'lon': 23.58333}}, {'zip': '011191', 'city': 'Bucharest', 'country': 'Romania', 'facility': '"Filantropia" Clinical Hospital; Gynecological Oncology', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '400015', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Prof. Dr. I. Chiricuta Institute of Oncology', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '200347', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Centrul de Oncologie Sfantul Nectarie', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '300239', 'city': 'Timișoara', 'country': 'Romania', 'facility': 'Oncomed SRL', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}